Lotronex Warnings
Lotronex Information
Lotronex Warnings
Serious gastrointestinal adverse events, some fatal, have been reported with the use of Lotronex. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, blood transfusion, surgery, and death.
- Only physicians who have enrolled in Glaxo Smith Kline s Prescribing Program for Lotronex, based on their attestation of qualifications and acceptance of responsibilities, should prescribe Lotronex.
- Lotronex is indicated only for women with severe diarrhea-predominant IBS who have failed to respond to conventional therapy. Less than 5 percent of IBS is considered severe. Before receiving the initial prescription for Lotronex, the patient must read and sign the Patient-Physician Agreement.
- Lotronex should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis. Physicians should instruct patients to immediately report constipation or symptoms of ischemic colitis. Lotronex should not be resumed in patients who develop ischemic colitis. Physicians should instruct patients who report constipation to immediately contact them if the constipation does not resolve after discontinuation of Lotronex. Patients with resolved constipation should resume Lotronex only on the advice of their treating physician.
